Prospective data registration and clinical trials for particle therapy in Europe

被引:23
作者
Langendijk, Johannes A. [1 ]
Orecchia, Roberto [2 ]
Haustermans, Karin [3 ,4 ]
Zips, Daniel [5 ]
Balosso, Jacques [6 ,7 ,8 ]
Lacombe, Denis [9 ]
Lievens, Yolande [10 ,11 ]
Weber, Damien C. [12 ,13 ]
Grau, Cai [14 ]
Troost, Esther G. C. [15 ,16 ,17 ,18 ,19 ]
机构
[1] Univ Groningen, Univ Med Ctr Groningen, Dept Radiat Oncol, Groningen, Netherlands
[2] European Inst Oncol, Milan, Italy
[3] KU Leuven Univ Leuven, Dept Oncol, Lab Expt Radiotherapy, Leuven, Belgium
[4] Univ Hosp Leuven, Dept Radiat Oncol, Leuven, Belgium
[5] Univ Tubingen, Dept Radiat Oncol, Tubingen, Germany
[6] Univ Hosp Grenoble Alpes CHU GA, Dept Radiat Oncol & Med Phys, Grenoble, France
[7] IPNL Lyon, France HADRON Natl Res Infrastruct, Lyon, France
[8] Univ Grenoble Alpes, Grenoble, France
[9] EORTC, Brussels, Belgium
[10] Ghent Univ Hosp, Dept Radiat Oncol, Ghent, Belgium
[11] Univ Ghent, Ghent, Belgium
[12] Paul Scherrer Inst, ETH Domain, Ctr Proton Therapy, CH-5232 Villigen, Switzerland
[13] Univ Hosp Bern, Dept Radiat Oncol, Bern, Switzerland
[14] Aarhus Univ Hosp, Dept Oncol, Aarhus, Denmark
[15] Tech Univ Dresden, Helmholtz ZentrumDresden Rossendorf, Fac Med, OncoRay Natl Ctr Radiat Res Oncol, Dresden, Germany
[16] Tech Univ Dresden, Helmholtz ZentrumDresden Rossendorf, Univ Hosp Carl Gustav Carus, Dresden, Germany
[17] Tech Univ Dresden, Fac Med, Dept Radiotherapy & Radiat Oncol, Dresden, Germany
[18] Tech Univ Dresden, Univ Hosp Carl Gustav Carus, Dresden, Germany
[19] Helmholtz Zentrum Dresden Rossendorf, Inst Radiooncol OncoRay, Dresden, Germany
关键词
Proton therapy; Prospective data registry; Particle therapy; Model-based approach; QUALITY-ASSURANCE; RADIOTHERAPY; CANCER; FACILITY;
D O I
10.1016/j.radonc.2018.06.001
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
The overarching aim of work package 1 of the European Proton Therapy Network (EPTN) is to create a firm basis for evidence-based particle therapy at the European level. To achieve this, this work package will set up a worldwide unique prospective data registration programme for nine different tumour sites. Such programme will provide more insights into the current practice across all European particle therapy centres and into the results of particle therapy with regard to radiation-induced toxicity and efficacy in terms of local control and survival. More importantly, prospective data registration provides major opportunities to continuously improve the quality of particle therapy, by defining bench marks, to identify best practices that may learn others to improve quality of particle therapy, to synchronize selection criteria and to create more homogeneous patient cohorts to evaluate results, which is particularly important in rare tumours. This will be supported by EORTC through existing and new IT-infrastructure for data collection in different formats next to QA-platforms. In addition, work package 1 will define the requirements for high quality clinical trials in order to enhance high quality clinical trial proposals and determine alternative methods for RCT, such as the model-based approach. (C) 2018 Elsevier B.V. All rights reserved.
引用
收藏
页码:9 / 13
页数:5
相关论文
共 15 条
[1]  
[Anonymous], 2014, EV NEW TECHN HLTH CA
[2]  
[Anonymous], 2009, PROT RAD
[3]   External validation of three dimensional conformal radiotherapy based NTCP models for patient-rated xerostomia and sticky saliva among patients treated with intensity modulated radiotherapy [J].
Beetz, Ivo ;
Schilstra, Cornelis ;
van Luijk, Peter ;
Christianen, Miranda E. M. C. ;
Doornaert, Patricia ;
Bijl, Henk P. ;
Chouvalova, Olga ;
van den Heuvel, Edwin R. ;
Steenbakkers, Roel J. H. M. ;
Langendijk, Johannes A. .
RADIOTHERAPY AND ONCOLOGY, 2012, 105 (01) :94-100
[4]   EORTC Radiation Oncology Group quality assurance platform: Establishment of a digital central review facility [J].
Fairchild, Alysa ;
Aird, Edwin ;
Fenton, Paul A. ;
Gregoire, Vincent ;
Gulyban, Akos ;
Lacombe, Denis ;
Matzinger, Oscar ;
Poortmans, Philip ;
Ruyskart, Pascal ;
Weber, Damien C. ;
Hurkmans, Coen W. .
RADIOTHERAPY AND ONCOLOGY, 2012, 103 (03) :279-286
[5]   A systematic review of the quality of statistical methods employed for analysing quality of life data in cancer randomised controlled trials [J].
Hamel, Jean-Francois ;
Saulnier, Patrick ;
Pe, Madeline ;
Zikos, Efstathios ;
Musoro, Jammbe ;
Coens, Corneel ;
Bottomley, Andrew .
EUROPEAN JOURNAL OF CANCER, 2017, 83 :166-176
[6]   Selection of patients for radiotherapy with protons aiming at reduction of side effects: The model-based approach [J].
Langendijk, Johannes A. ;
Lambin, Philippe ;
De Ruysscher, Dirk ;
Widder, Joachim ;
Bos, Mike ;
Verheij, Marcel .
RADIOTHERAPY AND ONCOLOGY, 2013, 107 (03) :267-273
[7]  
Leroy R, 2015, KCE REPORTS, V235
[8]  
Luhr A, CLIN TRANSLATIONAL R
[9]   Clinical evaluation of atlas and deep learning based automatic contouring for lung cancer [J].
Lustberg, Tim ;
van Soest, Johan ;
Gooding, Mark ;
Peressutti, Devis ;
Aljabar, Paul ;
van der Stoep, Judith ;
van Elmpt, Wouter ;
Dekker, Andre .
RADIOTHERAPY AND ONCOLOGY, 2018, 126 (02) :312-317
[10]   Rethinking pragmatic randomised controlled trials: introducing the "cohort multiple randomised controlled trial" design [J].
Relton, Clare ;
Torgerson, David ;
O'Cathain, Alicia ;
Nicholl, Jon .
BMJ-BRITISH MEDICAL JOURNAL, 2010, 340 :963-967